I-NEB AAD SYSTEM— 510(k) K042991

Substantially Equivalent

Profile Therapeutics Plc

FDA 510(k) clearance K042991 for I-NEB AAD SYSTEM, Substantially Equivalent on 2005-09-23. Applicant: Profile Therapeutics Plc.

Clearance details

Applicant: Profile Therapeutics Plc
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2004-11-01
Decision date: 2005-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.